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CTRI Number  CTRI/2021/08/035803 [Registered on: 19/08/2021] Trial Registered Prospectively
Last Modified On: 16/01/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Choice of Antibiotics for the Treatment of Infection in Newborns 
Scientific Title of Study   Efficacy and Safety of Ampicillin and Gentamicin versus Piperacillin-tazobactam and Amikacin for the Treatment of Neonatal Sepsis: A Randomized Controlled Trial  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ashok Kumar 
Designation  Professor 
Affiliation  Banaras Hindu University 
Address  Department Of Pediatrics, Institute Of Medical Sciences, Banaras Hindu University, Varanasi

Varanasi
UTTAR PRADESH
221005
India 
Phone  09415300370  
Fax    
Email  ashokkumar_bhu@hotmail.com  
 
Details of Contact Person
Scientific Query  
Name  Ashok Kumar 
Designation  Professor 
Affiliation  Banaras Hindu University 
Address  Department Of Pediatrics, Institute Of Medical Sciences, Banaras Hindu University, Varanasi

Varanasi
UTTAR PRADESH
221005
India 
Phone  09415300370  
Fax    
Email  ashokkumar_bhu@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Brijesh Kumar 
Designation  Junior Resident 
Affiliation  Banaras Hindu University 
Address  Department Of Pediatrics, Institute Of Medical Sciences, Banaras Hindu University, Varanasi

Varanasi
UTTAR PRADESH
221005
India 
Phone    
Fax    
Email  kazibrijesh012@gmail.com  
 
Source of Monetary or Material Support  
SS Hospital, Banaras Hindu University, Varanasi 
 
Primary Sponsor  
Name  Banaras Hindu University 
Address  Department Of Pediatrics, Institute Of Medical Sciences, Banaras Hindu University, Varanasi 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Prof Ashok Kumar  Second Floor, Neonatal Unit, Department of Pediatrics  Department Of Pediatrics, Institute Of Medical Sciences, Bananas Hindu University, Varanasi
Varanasi
UTTAR PRADESH 		 09415300370

ashokkumar_bhu@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: P369||Bacterial sepsis of newborn, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Injection Ampicillin and Gentamicin  Injection Ampicillin and Gentamicin will be administered to newborns with suspected or confirmed sepsis using standard doses for newborns adjusted to gestational age, birth weight and postnatal age. 
Intervention  Injection Piperacillin-tazobactam and Amikacin   Injection Piperacillin-tazobactam and Amikacin will be administered to newborns with suspected or confirmed sepsis using standard doses for newborns adjusted to gestational age, birth weight and postnatal age. 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  28.00 Day(s)
Gender  Both 
Details  Clinical Symptoms (2 or more)
1 If core body temperature more than 38.5°C or less than 36°C or temperature instability.
2 Cardiovascular instability: bradycardia(heart rate below 80/minute) or tachycardia(heart rate above 180/minute) or reduced urinary output (less than 1 ml/kg/hour)or hypotension requiring volume or inotropic support, or mottled skin or capillary refilling time more than 3 seconds
3 Respiratory instability: apnea(cessation of breathing for more than 20 seconds) or tachypnea(respiratory rate more than 60/minute)or episodes or increased oxygen requirement by more than 10% or requirement of ventilatory support
4 Petechial rash or sclerema
5 Feeding intolerance or poor sucking or abdominal distension
6 Central nervous system: irritability or lethargy or hypotonia or seizures
7 Cellulitis or skin ulceration
Laboratory signs (2 or more)
1 White blood cells (WBC) count: below 4,000/cubic mm or above 20,000 cubic mm
2 Platelet count below 100,000 cubic mm
3 Immature to total neutrophil ratio above 0.2
4 C reactive protein above 10 mg/L or Procalcitonin levels above hourly reference values after birth
5 Glucose intolerance: hyperglycemia (blood glucose above 180 mg/dL) or hypoglycemia (blood glucose below 45mg/dL)
6 Metabolic acidosis: Base excess (BE) below -10 mEq/L or Serum lactate above 2 mMol/L
7 Chest xray suggestive of bronchopneumonia
8 Cerebrospinal fluid changes suggestive of septic meningitis
 
 
ExclusionCriteria 
Details  1. Newborns receiving antibiotics for 3 days or less
2. Major congenital malformations
3. Failure to obtain consent 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Treatment failure will be defined as a need for changing initial antibiotics regimen within 72 hours or earlier if treating physician considers it necessary in view of rapidly deteriorating clinical condition of newborn  Within 72 hours 
 
Secondary Outcome  
Outcome  TimePoints 
1. Death at 3 days of age
2. Death at 7 days of age
3. Death at 1 month of age
4. Adverse effects of therapy 		 3 days, 1 week and 1 month 
 
Target Sample Size   Total Sample Size="180"
Sample Size from India="180" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   23/08/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [ashokkumar_bhu@hotmail.com].

  6. For how long will this data be available start date provided 10-01-2023 and end date provided 07-01-2025?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   In this study we will compare the efficacy and safety of Injection ampicillin and gentamicin versus Injection piperacillin-tazobactam and amikacin for the teatment of suspected or confirmed neonatal sepsis.Neonatal sepsis will be suspected on the basis of criteria given by the European Medicines Agency, 2010. Sepsis work up will include CBC, CRP, blood culture, and CSF examination and culture, if needed. Other relevant investigations such as chest xray, ABG, renal and liver function tests, cranial sonography, echocardiography will be done as per need. Newborns with suspected or confirmed sepsis will be randomized to Injection ampicicillin and gentamicin or piperacillin-tazobactam and amikacin, using random permuted blocks of variable size. Randomization sequence will be prepared by a person not involved in study. Newborns will be allocated using serially numbered opaque and sealed envelops. Primary outcome variable of the study is the need for change of initial antibiotic regimen within 72 hours or earlier if treating physician considers it necessary in view of rapidly deteriorating clinical condition of baby. Antibiotics will be changed under the following circumstances(one or more): Failure to improve or worsening of clinical status, new or worsening infiltrates on chest xray, CRP rise of more than 10 mg per decilitre in an unwell newborn, isolation of bacteria resistant to initial antibiotic regimen in an unwell newborn. Complications will be managed as per unit protocol. The duration of antibiotics will be 5-7 days for clinical sepsis, 10-14 days for culture-positive sepsis, and 21 days for meningitis. Lumbar puncture will be done as per the discretion of the treating physician.. LP will be done in those cases where the suspicion of meningitis is high, such as late onset sepsis, or if the blood culture is positive in early onset sepsis. However, generally it will be the discretion of treating physician to subject a newborn to LP.  Initial LP will be delayed for 24-48 hours in critically sick newborns. Clinical and laboratory data will be recorded on a pre-designed proforma. 
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